(20 days)
Not Found
No
The summary describes a purely mechanical device for creating surgical anastomoses and contains no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended to create an aortic anastomosis, which is a surgical procedure to connect blood vessels. This falls under the definition of a therapeutic device as it directly treats a medical condition or facilitates a surgical intervention.
No
The device description clearly states it is a "mechanical device used to facilitate an aortic vein graft anastomosis" and "replaces sutures to create a secure, patent and reproducible anastomosis." This describes a surgical tool used for treatment, not a device that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "mechanical device" consisting of a "connector and a delivery system," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create the aortic anastomosis of aortic autologous vein grafts." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as a "mechanical device used to facilitate an aortic vein graft anastomosis." This further reinforces its role in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The PAS-Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary in vitro and in vivo testing has been performed on the PAS-Port® Proximal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K091017 Pg 10f 2 PAS-Port® Proximal Anastomosis System
510(k) Summary
APR 2 9 2009
PAS-Port™ Proximal Anastomosis System
| 510(k) Number | |
|---|---|
| Date Prepared | April 7, 2009 |
| Applicant Information | 900 Saginaw |
| Redwood City, California 94063 | |
| Main: 650-364-9975 | |
| Fax: 650-331-7195 | |
| Contact Person | Kimberlee Leon |
| Office: 650-331-7119 | |
| Fax: 650-331-7195 | |
| e-mail: leon@cardica.com | |
| Establishment Registration Number | 3004114958 |
| Device Information | Classification Name: Clip, Implantable |
| Regulation Number: 21 CFR §878.4300 | |
| Trade Name: Cardica® PAS-Port® Proximal Anastomosis System | |
| Common Name: Cardiovascular Surgical Instruments | |
| Legally Marketed Predicate Device(s) | PAS-Port® Proximal Anastomosis System (K081225) |
| Device Description | The Cardica® PAS-Port® Proximal Anastomosis System is a |
| mechanical device used to facilitate an aortic vein graft | |
| anastomosis. The connector replaces sutures to create a | |
| secure, patent and reproducible anastomosis. The PAS-Port® | |
| Proximal Anastomosis System consists of a connector and a | |
| delivery system. |
·
1
| Indications for Use | The PAS-Port® System is intended to create the aortic
anastomosis of aortic autologous vein grafts. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Device | The PAS-Port® Proximal Anastomosis System is substantially
equivalent to the PAS-Port® Proximal Anastomosis System
(K081225, 21 CFR §878.4300). |
| Device Testing
Results and
Conclusion | All necessary in vitro and in vivo testing has been performed
on the PAS-Port® Proximal Anastomosis System and its
packaging to ensure substantial equivalence to the predicate
device, and to ensure the safety and effectiveness of the
device. |
| Technological
Characteristics | See Device Description above. |
| Substantial
Equivalence
Summary | Both, the Cardica® PAS-Port® Proximal Anastomosis System
have the same indications for use and the same technological
characteristics as the predicate device (K081225). This
premarket notification has described the characteristics of the
modified device in sufficient detail to assure substantial
equivalence. |
| Conclusions | This Special 510(k) for Device Modification submission has
demonstrated Substantial Equivalence as defined and
understood in the Federal Food Drug and Cosmetic Act and
various guidance documents issued by the Center for Devices
and Radiological Health. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2009
Cardica, Inc. c/o Ms. Kimberlee Leon Manager, Quality Systems 900 Saginaw Drive Redwood City, CA 94063
Re: K091017
Cardica® PAS-Port® Proximal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class II Product Code: FZP Dated: April 7, 2009 Received: April 9, 2009
Dear Ms. Leon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Kimberlee Leon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. becher
ABram D. Zuckerman, M.D. > Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K091017 PAS-Port® Proximal Anastomosis System
. Indications for Use Statement 510(k) Number: K091017 (if known) Cardica® PAS-Port® Proximal Anastomosis System Device Name: The Cardica® PAS-Port® Proximal Anastomosis System is intended to Indications for Use: create the aortic anastomosis of aortic autologous vein grafts.
Prescription Use X (Part 21 CFR§801.109)
.
Over-The-Counter Use OR (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dname R. Liciason
(Division Sign-Off)
Division of Cardiovascular Devices
H. Indications for Use Statement
510(k) Number Korano(7
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